None listed
Conditions
Interventions
Dietary Supplement : 1) Study Product
Active Ingredient: Green tea seed and leaf extract complex
Appearance and Dosage Form: Capsules with unique color tag, strange taste, and no strange smell
Conten
Sponsors
The Catholic University of Korea, St. Vincent's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female adults aged 19 to 70 years old at the start study2) Individuals with diagnosed with functional dyspepsia * Subjects who have at least one of the symptoms of dyspepsia* classified as Rome IV and do not require prompt medication (when symptoms start 6 months prior to visit 1 and have symptoms for the past 3 months) - Bothersome early satiation - Bothersome postprandial fullness after a meal - unpleasant epigastric pain - unpleasant epigastric burning 3) Subjects capable of understanding and complying with the test method and progress of this Clinical Study 4) Subcjets has no difficulty in conducting the questionnaire conducted in this Clinical Study 5) Subjects who agreed to participate in this study and voluntarily signed a written consent for
Exclusion criteria
Exclusion criteria: 1) Subjects who are unable to perform upper gastrointestinal endoscopy 2) Subjects who have ulcers, cancer, hemorrhagic gastritis, etc. that require treatment on upper gastrointestinal endoscopy, or are judged to have a tendency to bleed in the gastrointestinal tract 3) Subjects who are judged to have ulcers, cancer, hemorrhagic gastritis, etc. that require treatment by endoscopy of the upper gastrointestinal tract, or to have a tendency to bleed in the gastrointestinal tract(active peptic ulcer, hemorrhagic gastritis, gastric or esophageal cancer, pancreatic disease, biliary tract disease, inflammatory bowel disease) within 3 months prior to start study 4) Subjects who need to continually take daily drugs that can cause ulcers, such as steroids, nonsteroidal anti-inflammatory drugs, and aspirin.(However, low-dose aspirin is allowed for the purpose of preventing cardiovascular disease) 5) Subjects diagnosed with drug-uncontrolled hypertension, diabetes, cerebrovascular disease, and conditions requiring surgery during the human body application trial within 3 months 6) Subjects who took drugs within 2 weeks prior to start study, such as antibiotics, bismuth compound, H2 receptor antagonists, proton pump inhibitors, mucosal protective agents, etc ((However, if other conditions are met at the discretion of the test manager, you may participate in the study.) 7) Subjects with a history of myocardial infarction, stroke, or clinically meaningful cardiovascular disease (arrhythmia, unstable angina, heart failure) within 3 months prior to start study 8) Subjects with a clinically significant history of severe pancreatic disease, biliary tract disease, thyroid disease, malignancy, etc 9) subjects who drink continuously more than four times a week 10) Subjects who have received antipsychotic medication within 3 months prior to start study or are suspected of mental illness 11) Subjects with a history of significant hypersensitivity reactions or side effects to test product constituents 12) Subjects who participated in other Clinical tests within 2 months prior to start study 13) Subjects who are suspected of alcoholism or substance abuse or have a therapeutic history 14) Subjects who are pregnant, breastfeeding 15) Subjects with the following results in diagnostic laboratory medical examination ? AST (GOT) or ALT (GPT) is at least three times the normal upper limit ? Serum Creatinine > 2.0mg/dl 16) Subjects deemed unsuitable by the researcher due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average change in Gastrointestinal Symptom Scale (K-GSRS) total score over 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal Symptom Scale (K-GSRS) Improved figures for each item;Changes in the Korean version of Nephrotic Indigestion Index (NDI-K) score;Changes in FD-QOL(Functional dyspepsia-related quality of life) score;Changes in GIS(Gastrointestinal symptom scale) score;Changes in hs-CRP, TNF-a, Malondialdehyde, MDA,Gastrin score | — |
Countries
Korea, Republic of
Contacts
Public ContactSong Sang Wuk
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed